ChiCTR-DDT-13003724 版本V1.1 版本创建时间2016/5/2 22:16:48 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR-DDT-13003724 

最近更新时间:

Date of Last Refreshed on:

2016/5/2 22:15:07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

建立HBV相关肝脏纤维化无创诊断标准/模型的研究 

Public title:

Prospective Evaluating hepatic fibrosis related to HBV using Non-invasive methods 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

建立HBV相关肝脏纤维化无创诊断标准/模型的研究 

Scientific title:

Prospective Evaluating hepatic fibrosis related to HBV using Non-invasive methods 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

赵鸿 

研究负责人:

赵鸿 

Applicant:

Hong Zhao 

Study leader:

Gui-Qiang Wang 

申请注册联系人电话:

Applicant telephone:

+86 13810765943 

研究负责人电话:

Study leader's telephone:

+86 13911405123 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

minmin2001@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

john131212@hotmail.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

北京西城区西什库大街8号北大医院感染疾病科 

研究负责人通讯地址:

北京西城区西什库大街8号北大医院感染疾病科 

Applicant address:

8 Xishiku Street, Xicheng District, Beijing, China 

Study leader's address:

8 Xishiku Street, Xicheng District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

北大医院感染疾病科 

Applicant's institution:

Department of Infectious Diseases, Peking University First Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

2013-08-26

研究实施负责(组长)单位:

北京大学第一医院 

Primary sponsor:

Peking University First Hospital 

研究实施负责(组长)单位地址:

北京西城区西什库大街8号 

Primary sponsor's address:

8 Xishiku Street, Xicheng District, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

国家卫生计划生育委员会

具体地址:

北京市西城区西直门外南路1号

Institution
hospital:

National Health and Family Planning Commission of the People's Republic of China

Address:

14 Zhichun Road Beijing

经费或物资来源:

中华人民共和国财政部 

Source(s) of funding:

Ministry of Finance of the People′s Republic of China 

研究疾病:

乙型肝炎 

Target disease:

Chronic infection with Hepatitis B virus 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

目前肝纤维化的诊断和药物疗效判断标准是肝脏穿刺活检、病理组织学检查,但存在有创、标本误差、判读误差等局限性,而国外已有无创诊断模型不但有自身的局限、也不适合我国国情。因此,亟待研发适合我国国情、HBV相关肝纤维化/肝硬化无创诊断标准和模型。本研究拟建立2000例不同纤维化程度的、HBV慢性感染者大样本研究标本库和数据库,用血清学、影像学等无创指标建立适用于不同医疗水平的HBV相关肝纤维化/肝硬化无创诊断模型。 

Objectives of Study:

The aim of our prospective study is to construct and validate a non-invasive model consisting biochemical markers, FibroScan, and radiological parameters for evaluating liver fibrosis caused by hepatitis B virus in mainland China. 

研究设计:

诊断试验诊断准确性 

Study design:

Diagnostic test for accuracy 

纳入标准:

1.18-65 岁、性别不限 2.HBsAg阳性6个月以上 3.同意行肝脏活检穿刺术 

Inclusion criteria

1.Male or female aged 18 to 65 years old2.HBsAg positive for 6 months3.agree to have liver biopsy 

排除标准:

1.抗HAV-IgM、抗-HCV、抗-HEV-IgM/IgG、抗-EBV-IgM、抗-CMV IgM阴性;并除外酒精、药物、自身免疫等其他原因所致慢性肝损伤 2.血小板计数≤ 80 × 10E9/mm3 3.凝血酶原活动度≤ 60% 4.医生认为受试者存在不适宜继续本临床研究的情况 

Exclusion criteria:

1.Patients with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease,nonalcoholic liver disease or other chronic liver disease; 2.PLT < 80×10 < 9 >/L; 3.PTA ≤ 60%; 4.patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject. 

研究实施时间:

Study execute time:

From2013-01-01To 2015-12-31 

干预措施:

Interventions:

组别:

One cohort

样本量:

2000

Group:

one cohort

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

肝脏活检

指标类型:

主要指标 

Outcome:

liver biopsy

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清学指标

指标类型:

主要指标 

Outcome:

serum parameters

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

影像学指标

指标类型:

主要指标 

Outcome:

radiological parameters

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

fibroscan test

指标类型:

主要指标 

Outcome:

fibroscan test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

不适用

Randomization Procedure (please state who generates the random number sequence and by what method):

Not Applicable

UTN(全球唯一识别码):

盲法:

Blinding:

试验完成后的统计结果:

无创纤维化评估乙肝病毒所致肝纤维化程度的模型

Calculated Results ater
the Study Completed:

Evaluating hepatic fibrosis related to HBV using Non-invasive methods

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

北京大学第一医院

Data collection Institution:

Peking University First Hospital

资料管理单位:

北京大学第一医院

Data management Institution:

Peking University First Hospital

资料分析单位:

北京大学第一医院

Data analysis Institution:

Peking University First Hospital

注册人:

Name on Registration:

 2013-10-01